Description
We are looking for a
Regulatory Affairs Manager for phytopharmaceuticals and homeopathic products (m/f)
Reference: -en
Start: asap
Duration: 3 MM++
Place: in Berlin
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Preparation and writing of registration dossiers (part 2 and 3 / CMC)
- Saving of regulatory compliance
- To check the documents for completeness and plausibility
- Independent preparation of the Quality Overall Summary (Module 2.3)
- Preparation of professional answering letters foreign authorities
- To support internal regulatory advice for product development and quality changes (change control)
Your qualifications
- University degree in natural sciences (pharmacy, chemistry, biology, medicine, etc.) or equivalent professional experiences
- Profound knowledge of international and national pharmaceutical legislation and quality documentation
- Experience with phytopharmaceuticals and homeopathic products
- Experience in creating and dealing with eCTD
- Very good knowledge of English and German
Skills:
- Regulatory affairs associate